| Sumario: | Background Since the heyday of HTA it has been claimed that ethics is an integral part of HTA. However, few HTA reports have addressed moral issues, and there has been little agreement on methods for implementing ethics in HTA. Therefore, there is a need to develop a standard methodology for addressing ethical issues in HTA in the same manner as there is a methodology for systematic reviews and economic analysis. Accordingly, the purpose of this report is to present a practical method for addressing moral issues in HTA. The method has to be applicable without special knowledge in ethics, and when applied, the method shall result in a broad basis for an open and transparent decision process. Accordingly, it shall only highlight the moral issues, and not lead to specific recommendations. Method On the basis of analyses and assessments of existing methods in ethics in general and in HTA in particular, a practical procedure for addressing moral issues in HTA is to be developed and presented. Results A practical method for addressing moral issues in HTA is presented. The method consists of a procedure in six steps:1. Identify and analyze the moral challenges with the health technology2. Identify involved persons, groups, and stakeholders3. Identify relevant moral questions (from a list of questions) and justify the selection4. Perform literature search in accordance with the identified moral questions5. Analyze and discuss the moral questions identified (in step 3) on the basis of1.1. The literature search1.2. Hearings of involved parties or qualitative studies6. Wrap up and summarize the process. The core set of moral questions in step 3 belong to the following main groups: 1. General moral issues. 2. Moral issues related to stakeholders 3. Moral issues related to the health technology. 4. Moral issues related to methodological choices in HTA. 5. Moral issues related to HTA itself. Addressing the moral issues shall result in a broad basis for an open and transparent decision process. Conclusion A practical procedure has been developed for ethical analysis in HTA, based on an analysis of existing methods. The procedure is based on six steps and a selection of 32 moral issues to be addressed.
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